Kornimate/medical-research-clean huggingface dataset:
observational registry characterizing the ctag device with active control

Conditions: Thoracic Diseases

Summary: collect real-world clinical and device-specific outcomes of the gore® tag® conformable thoracic stent graft featuring active control system (ctag device with active control) in the treatment of aortic disease as part of routine clinical practice.

this is an observational, prospective, single-arm, post-market registry designed to collect real-world clinical and device specific outcomes of the gore® tag® conformable thoracic stent graft featuring active control system (ctag device with active control) in the treatment of aortic disease as part of routine clinical practice. a maximum of 20 clinical investigative sites in europe will participate and up to 125 patients will be enrolled in this registry. all consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the ctag device with active control will be included and followed through one year per institutional standard of care.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. signed informed consent form 3. willingness, in the opinion of the investigator, to adhere to standard of care follow-up requirements 4. surgical indication for tevar based on investigator's best medical judgment 5. intent to treat with ctag device with active control. exclusion criteria: 1. paraplegia or paraparesis at initial presentation 2. participation in concurrent research study or registry which may confound registry results, unless approved by sponsor 3. prior implantation of a thoracic stent graft 4. pregnant or breast-feeding female at time of informed consent signature 5. life expectancy \< 1 year due to comorbidities

Keywords: ctag tevar
pre-surgery physiotherapy for patients with specific low back pain

Conditions: Lumbar Spine Disc Herniation; Spinal Stenosis; Spondylolisthesis, Grade 4

Summary: the aim is to study if pre-surgery physiotherapy improves function, pain and health in patients with specific low back pain scheduled for surgery. patients are followed over a two year period. a secondary aim is to study what factors predict short and long term outcomes.

the design is a randomized controlled trial, where patients are allocated either to pre-surgery physiotherapy or waiting-list when scheduled for surgery due to specific low back pain (spinal stenosis, disc herniation, spondylolisthesis, disc degenerative disease (ddd)). the patients are scheduled for surgery due to specific low back pain diagnosis and randomized to either pre-surgery physiotherapy or waiting-list group. clinical measurement and treatment-classification is done before and after intervention. pre-surgery intervention: physiotherapy guided intervention twice a week for nine weeks. the program includes: 1. active physiotherapy according to a treatment based classification 1. specific exercises and mobilization 2. motor control exercises 3. traction 2. tailor-made general supervised exercise program 3. behavioral approach to reduce fear avoidance and increase activity level. both groups receive standardized information about surgery, post-surgery rehabilitation and to stay active. surgery in performed according to existing guidelines. measurements: patients fill out a questionnaire at baseline, before surgery (after pre-surgery physiotherapy or waiting-list), three months, one and two years after surgery. the questionnaire includes self-reported measures for function oswestry disability index (odi) (primary outcome), pain (vas, pain drawing, pain duration) and health (sf-36, eq-5d), anxiety, depression (hads), self efficacy, fear avoidance belief questionnaire (fabq), workability, (wai), expectations, general information of work, sick-leave, lifestyle behavior, previous healthcare consumption, patient reported treatment effects, patient enablement instrument (pei), and adverse events. clinical measurement is done before and after intervention. clinical measurements includes; isometric quadriceps strength, walking-test, neurological tests for l4-s1, si-joint tests, posterior-anterior-test (pa-test), test for centralization, test for aberrant movements.

Eligibility criteria:
inclusion criteria: patients that are scheduled for surgery due to following diagnoses; * disc herniation, * spinal stenosis, * spondylolisthesis, * degenerative disc disease. * fluent in swedish. exclusion criteria: * need of acute surgery * other severe diagnoses.

Keywords: physical therapy lumbar spine surgery pre-surgical intervention rct
extended mesenteric excision in ileocolic resections for crohn's disease

Conditions: Crohn Disease; Recurrence; Crohn's Ileocolitis

Summary: the study is looking at the role of the mesentery in disease recurrence for ileocolic crohn's disease. it is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for crohn's disease. endoscopic recurrence will be monitored with the hypothesis that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. (limited mesenteric resection).

the current standard of care for ileocolic crohn's disease (cd) is a limited mesenteric resection. there is growing, but still limited, evidence that extended mesenteric excision during ileocolic resection is beneficial in decreasing disease recurrence. we propose a prospective multicenter cohort study to better understand the role of extended mesenteric excision in ileocolic cd and how it affects disease recurrence. the primary outcome of this study will be the rate of endoscopic recurrence at 6 months in patients undergoing first-time resection for ileocolic cd. secondary outcomes will include endoscopic recurrence at 18 months and rates of recurrence requiring surgery by 2 years. these outcomes will be compared to historical controls (limited mesenteric resection). our hypothesis is that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. as seen in previous studies, advanced mesenteric and mucosal disease predicts increased surgical recurrence.

Eligibility criteria:
inclusion criteria: adults \>18 years old diagnosis of cd limited to the distal ileum/ileocolic region no previous ileocolic resection all forms of cd presentation will be included - stricturing, fistulizing, perforating etc. exclusion criteria: previous ileocolic resection other sites of cd intraabdominal sepsis
immunogenicity and safety of an inactivated non-adjuvanted a(h1n1)v influenza vaccine in pregnant women

Conditions: Influenza

Summary: the purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non adjuvanted a(h1n1)v influenza vaccine in 120 pregnant women. study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery and recording temperature and vaccine side effects in a memory aid for 7 days following each vaccination. participants will be involved in study related procedures about 3 at 5 months.


Eligibility criteria:
inclusion criteria: * 18 years to 45 years * pregnancy between 22 and 32 weeks of gestation * provides written informed consent * covered by french social security exclusion criteria: * allergy to eggs or other components in the vaccine * history of severe reactions following previous influenza vaccines * h1n1 influenza (virologically documented) during the last 6 months * febrile episode within one week prior to vaccination * known hiv, hbv, hcv infection * multiple sclerosis * history of guillain-barré syndrome * organ transplant recipient * neoplastic disease in the past 3 years * other vaccine within 3 weeks prior to study entry or planned within the month following the last injection * systemic corticosteroids,immunotherapy,chemotherapy * anticoagulant treatment * immunoglobulin or blood transfusion within the 3 months prior to enrollment in this study * history of cardiac disease * chronic liver disease * diabetes before pregnancy * history of premature delivery * history of eclampsia * fetal morphologic abnormalities

Keywords: influenza vaccine pregnancy
evaluation of intraocular pressure using simbrinza™ in patients with open-angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to evaluate intraocular pressure (iop) over a 24-hour period using simbrinza™ topical ophthalmic suspension.

this study consisted of two phases, a screening/eligibility phase and a treatment phase. both phases required the patient to complete an overnight stay.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes. * willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments. * must sign an informed consent form. * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control. * severe central visual field loss in either eye. * chronic, recurrent or severe inflammatory eye disease. * ocular trauma or ocular surgery within the past 6 months. * ocular infection or ocular inflammation within the past 3 months. * clinically significant or progressive retinal disease. * other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication. * any other conditions including severe illness which would make the patient, in the opinion of the investigator, unsuitable for the study. * any medical condition that would preclude the safe administration of a topical beta-blocker. * cannot safely discontinue all glucocorticoids administered by any route. * other protocol-specified exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension simbrinza™ intraocular pressure
post-partum depression, breastfeeding adherence and fear in covid-19

Conditions: Breast Feeding, Exclusive; Post Partum Depression; Covid19

Summary: this study aims to explore whether quarantine measures, social distancing and hospital containment policies among women giving birth during the covid-19 pandemic enhanced psycho-emotional distress in the immediate postpartum period. the investigators tested for depression using the edinburgh postnatal depression scale (epds) in the first 6 postpartum months, and then used the fear of covid-19 scale, measuring also the adherence and practices of breastfeeding according to who.


Eligibility criteria:
inclusion criteria: * women aged ≥18 years * women who delivered singletons at term in the last 6 months during the covid-19 pandemic exclusion criteria: * women who delivered two or more products * women who delivered singletons at term past the last 6 months during the covid-19 pandemic * women who delivered singletons pre or post-term in the last 6 months during the covid-19 pandemic

Keywords: covid-19 post-partum depression breast feeding pandemic
phase 1 to study safety, tolerability, pharmacokinetics, and pharmacodynamics of na-931 in obese participants and patients with type 2 diabetes mellitus

Conditions: Overweight or Obesity; Type 2 Diabetes

Summary: a randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of na-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with t2dm.

a randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of na-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with type 2 diabetes mellitus. na-931 is a quadruple receptor agonist for insulin like growth factor 1 (igf-1), glucagon-like peptide-1 (glp-1), gastric inhibitory polypeptide (gip) and glucagon.

Eligibility criteria:
inclusion criteria: * participants 18-65 years old, inclusive * bmi of 25 - 40, inclusive * stable body weight for two months * participants must be capable of giving signed informed consent * willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures * willing to comply with contraception requirements exclusion criteria: * history of significant medical conditions and malignancy * uncontrollable hypertension * history of alcoholism or drug addiction within 1 year prior to screening * current or recent participation in an investigational clinical trial * any surgical or medical condition (active or chronic) that may interfere with ip distribution, metabolism, excretion, or drug absorption

Keywords: na-931, obesity, type 2 diabetes, biomed industries, inc
suspension of mechanical ventilation in ureteroscopic lithotripsy under general anesthesia

Conditions: Hypercapnia; Hypoxia

Summary: for some upper ureteral and renal stones,ureteroscopic lithotripsy needs to be performed under general anesthesia with interrupted suspension of mechanical ventilation, which could result in hypercapnia and hypoxia. in this study, the investigators hypothesize that 10 cmh2o peep added to the respiratory circuit with 1 l/min 100% oxygen might extend the time of ventilation suspension but have no effect on carbon dioxide retention in blood.

for some upper ureteral and renal stones,ureteroscopic lithotripsy is often perdurbed by the patient's respiratory movement either under epidural anesthesia or general anesthesia with mechanical ventilation. so intermittent suspension of mechanical ventilation under general anesthesia can ensure the surgery to be performed continuously and successfully. but this could result in hypercapnia and hypoxia. so far, there have been few studies focused on the change of the internal environment in blood as result of suspending breath. in this study, the investigators hypothesize that 10 cmh2o peep added to the respiratory circuit with 1 l/min 100% oxygen might extend the time of ventilation suspension but have no effect on carbon dioxide retention in blood.

Eligibility criteria:
inclusion criteria: asa i\~iii general anesthesia sign the informed consent exclusion criteria: asa iv or v woman who is pregnant or plans to bear
radiofrequency and cryoablation of the posterior wall of the left atrium

Conditions: Stroke; Acute Cerebrovascular Accident; Transient Ischemic Attack; Death; Atrial Fibrillation Recurrent

Summary: atrial fibrillation (af) is the cause of 20% of strokes, and the risk of stroke in a person suffering from this arrhythmia increases by 5 times. ischemic stroke in patients with af is often fatal and, compared with stroke of other etiology, leads to the most pronounced disability and more often recurs. accordingly, the risk of death in patients with af-related stroke is 2 times higher, and treatment costs increase 1.5 times. the main interventional method of treating af, available in most medical institutions, is the use of radio frequency and/or cryoenergy to eliminate destructive damage to the left atrium (la). the aim of this study is to compare two different interventional methods and identify predictors of recurrence in patients with persistent and long-term af.


Eligibility criteria:
inclusion criteria: * age over 18 years old; * atrial fibrillation resistant to antiarrhythmic therapy; * persistent and long-persisting form of atrial fibrillation; * the patient's consent to participate in the study. exclusion criteria: * age under 18 and over 80 years old; * the presence of another cardiac pathology requiring surgical treatment; * congenital heart defects; * previous "open" cardiac surgery; * bone marrow diseases; * pathology of the blood coagulation system; * the left ventricular ejection fraction is less than 40%; * moderate to severe renal insufficiency (creatinine clearance \<50 ml/min); * drug-resistant hypertension (despite hypotensive therapy); * organically altered mitral valve; * there are reasons to assume that the patient will not show up for subsequent visits (control points of the study) for various reasons; * the patient's participation in another clinical trial.

Keywords: atrial fibrillation radiofrequency ablation cryoablation left atrium the posterior wall of the left atrium atrial remodeling
high cessation rates in smokers using personal vaporizers

Conditions: Tobacco Addiction

Summary: e-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. second generation devices may result in much higher quit rates. their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated. in this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. product usage, number of cigarettes smoked, and exhaled carbon monoxide (eco) levels were measured at each visit. smoking reduction and abstinence rates were calculated. adverse events and participants' opinions of these products were also reviewed.


Eligibility criteria:
inclusion criteria:healthy smokers 18-60 years old, smoking ≥15 conventional cigarettes per day (cig/day) for at least 10 years were recruited using anti-smoking leaflets and by an approved kiosk located in the atrium of the university hospital (aou 'policlinico-v. emanuele') promoting the smoking cessation services of the cpct (centro per la prevenzione e cura del tabagismo, università di catania, italy). - exclusion criteria:history of alcohol and illicit drug use, major depression or other psychiatric conditions. we also excluded subjects who reported recent myocardial infarction, angina pectoris, essential hypertension (\>140mmhg systolic and/or \>90mmhg diastolic), diabetes mellitus, severe allergies, poorly controlled asthma or other airways diseases -
a study of investigational dulaglutide doses in participants with type 2 diabetes on metformin monotherapy

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy.


Eligibility criteria:
inclusion criteria: * have had type 2 diabetes (t2d) for ≥6 months according to the world health organization (who) classification * have hba1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory * have been treated with stable doses of metformin for at least 3 months * have a body mass index (bmi) ≥25 kilograms per square meter exclusion criteria: * have type 1 diabetes (t1d) * have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (glp-1 ras) at any time in the past * have had any of the following cardiovascular conditions: acute myocardial infarction (mi), new york heart association class iii or class iv heart failure, or cerebrovascular accident (stroke) * have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (nafld), or alanine aminotransferase (alt) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with nafld are eligible for participation in this trial * have had chronic or acute pancreatitis any time prior to study entry * have an estimated glomerular filtration rate (egfr) \<45 milliliters/minute/1.73 square meter, calculated by the chronic kidney disease-epidemiology (ckd-epi) equation * have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry
effect of mediterranean diet in inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: the effects of diet on inflammatory bowel disease is an under-studied area of research. the investigators are interested in further investigating the role that diet contributes to inflammatory bowel disease severity. the investigators will collect blood and stool samples from patients with inflammatory bowel disease (ibd) before and after diet changes. the stool samples will be analyzed using metabolomics and microbiome analysis to determine changes after the new diet has been implemented. the investigators will then compare changes in the patient's overall disease state by measuring markers of inflammation including c-reactive protein (crp) and fecal calprotectin to determine how this diet affects the disease state.


Eligibility criteria:
inclusion criteria: * 18 years old or older * meet classification criteria for inflammatory bowel disease including those with mild to moderate crohn's disease as defined by a crohn's disease activity index between 150-450, with fecal calprotectin\>250, within 1 month of enrollment. exclusion criteria: * unable to provide informed consent * history of or current drug abuse * pregnancy * start or change in dose of standard-of-care treatment within 12 weeks of the screening * known allergy to any component of the proposed diet * subjects with significant other medical or psychiatric comorbidities and /or medication use which in * physician's clinical judgment might difficult the interpretation of the results * patients that are not on a stable dose of medications, for instance, steroids, in between samples collection * patients on antibiotics * patients with c difficile infection within 4 weeks of enrollment
low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy

Conditions: Non-Functioning Kidney; Renal Cell Carcinoma

Summary: laparoscopic nephrectomies are commonly performed these days and are considered gold standard for both benign and malignant diseases as well as for donor nephrectomies. despite being a widely performed surgery worldwide still there are areas of uncertainties due to lack of evidences. one of such area of dilemma is the optimum pressure of pneumoperitoneum. this study aims to identify if lower pressure of pneumoperitoneum is safe during laparoscopic nephrectomies. this is a hospital based prospective randomized control study. all the patients undergoing laparoscopic nephrectomies at department of urology and kidney transplant surgery will be eligible for study. patients will be divided into low pressure or standard pressure pneumoperitoneum by simple random sampling and comparison of various intraoperative and post-operative parameters will be done to assess the safety of low pressure pneumoperitoneum


Eligibility criteria:
inclusion criteria: * all patients undergoing laparoscopic nephrectomy exclusion criteria: * age \<18 years * history of previous abdominal surgeries * laparoscopic donor nephrectomies